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Market Snapshot: Diabetic Macular Edema, Another Blockbuster Opportunity For Retinal Drugs?

 
• By John Davis

Having relatively rapidly built a multi-billion dollar market in wet age-related macular degeneration, biotech and pharma companies may be about to repeat the exercise with diabetic macular edema, a complication of diabetes that’s growing in importance as the population ages and the disease spreads.

Wet age-related macular degeneration (AMD) is receiving a lot of attention from industry, scientists and Wall Street these days, thanks to the enormous and rapid commercial success of new treatments for it.

But diabetic macular edema (DME), a common complication of diabetes, also could be a large opportunity –at least that’s the hope of companies working on retinal diseases. DME is the leading cause of blindness in young and middle-aged adults in developed countries

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Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 
• By Neena Brizmohun

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Nielsen Hobbs

This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Nielsen Hobbs

We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.

Brazil Pilots Digital Drug Pack Inserts

 
• By Francesca Bruce

A new pilot aims to take Brazil closer to ‘digital transformation.’

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Legal, Process Problems May Plague New US FDA COVID-19 Vaccine Policy

 
• By Sarah Karlin-Smith

The FDA may have violated laws and regulations along with many norms in how it released its planned changes for COVID-19 vaccine approvals.

Observational, Retrospective Trials Could Retest Vaccines, HHS’ Kennedy Says

 
• By Derrick Gingery

The Health and Human Services secretary told a Senate appropriations subcommittee that placebo-controlled trials may not be necessary to ensure vaccine safety as the FDA released a framework requiring them for COVID-19 vaccines.

HHS Negotiating With Manufacturers On Most Favored Nation Drug Pricing

 
• By Cathy Kelly

MFN policy would would apply to all single source drugs in all insurance markets, according to HHS release. Secretary Robert F. Kennedy Jr. said the department is discussing the plan with drug sponsors.